Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay

HIV-1 Infection Clinical Trial

Official title:

Collection of Plasma Samples From Human Immunodeficiency Virus (HIV) Type 1 (HIV-1) Infected Individuals for the Clinical Evaluation of the Aptima HIV-1 Quant Dx Assay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026752
• Other study ID #: HIVQPS-US12-001
• Secondary ID: HIVQPS-US12-002H
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: February 22, 2017
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1) infected individuals that have viral loads across the dynamic range of the Aptima HIV-1 assay. The plasma samples will be tested in a method comparison study to support the approval of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1 assay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: January 2017
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria

• The subject has documented HIV infection

• The subject is at least 15 years of age at the time of enrollment

• For ART subjects, subject has documented HIV-1 RNA levels above the lower limit of quantitation of an FDA-approved assay in a sample collected in the past 90 days.

• The subject (and/or legally authorized representative, if allowed) is willing and able to provide written informed consent before providing a specimen (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board [IRB]-approved waiver for parental consent for minors).

Exclusion Criteria

• A potential subject will be ineligible for the study if the subject, clinician, or medical record reports any of the following:

• Subject's HIV disease stage and/or current ART status is unknown.

• It is unknown if current or previous ART was changed or stopped due to therapy failure.

• For non-ART subjects, subject was previously on ART in the past 30 days

• Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study)

• Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study

• Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study

Related Conditions & MeSH terms

• HIV-1 Infection

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Jacobi Medical Center	Bronx	New York
United States	Wishard Health Services	Indianapolis	Indiana
United States	University of Miami - AIDS Clinical Research Unit	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Louisiana State University	New Orleans	Louisiana
United States	Palmtree Clinical Research Inc	Palm Springs	California
United States	UCSD - AnitViral Research Center (AVRC)	San Diego	California
United States	Community AIDS Network	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative detection of HIV-1 RNA	Regression parameters (intercept and slope) will be estimated from method comparison analysis.	single baseline visit